Toronto, Ontario – October 01, 2019, Theralase® Technologies Inc. (“Theralase” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds (“PDC”) and their associated drug formulations to safely and effectively destroy various cancers is pleased to announce today that the Company has filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) to initiate a Phase II, Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study II”) of Theralase’s anti-cancer Photo Dynamic Therapy (“PDT”) technology in patients using the Companies patented PDC, TLD-1433 combined with it’s proprietary TLC-3200 medical laser system.
Study II, entitled, “A Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Bacillus Calmette-Guerin (“BCG”) unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Patients or Patients who are Intolerant to BCG Therapy” was successfully launched at the University Health Network (“UHN”) with Theralase actively pursuing up to 4 additional clinical study sites in Canada. Pending FDA approval, the Company plans to launch up to 16 clinical study sites in the US. Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433, in the treatment of approximately 100 BCG-Unresponsive NMIBC patients presenting with Carcinoma In-Situ (“CIS”) in approximately 20 clinical study sites located in Canada and the US. The study will have a primary endpoint of efficacy (measured by Complete Response (“CR”)) at any point in time, a secondary endpoint of duration of CR at approximately 360 days post-initial treatment and a tertiary endpoint of safety measured by incidence and severity of adverse events grade 4 or higher that do not resolve within 360 days post-initial treatment .
In June 2019, a conference call with the FDA confirmed that the Company’s clinical protocol of Study II met FDA Guidance for Industry dated February 2018 on “BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment”. The guideline stated that “In BCG-unresponsive NMIBC, a single-arm clinical trial with complete response rate and duration of response as the primary endpoint can provide primary evidence of effectiveness to support a marketing application.”1
Shawn Shirazi, Ph.D., CEO – Drug Division, Theralase stated “Based on the high safety and the efficacy results demonstrated in the Phase Ib study, the TLD-1433 Anti-Cancer Technology (“ACT”) platform has the potential to be a viable treatment solution for NMIBC, if the Company is able to duplicate the efficacy results observed in the Phase Ib clinical study (67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and treated, Theralase plans to meet with the FDA to review the results, with a focus on obtaining accelerated approval of the Companies ACT-PDT.